ESTEEM+

Description of Event or Problem

IT WAS REPORTED BY THE DISTRIBUTOR THAT WAFER WITH STARTER HOLE WERE OFF CENTERED. THE PRODUCT WAS NOT USED BY PATIENT. NO PHOTO IS AVAILABLE AT THIS TIME.

Additional Manufacturer Narrative

DEVICE 3 OF 5. E1: COMPLAINANT STATE/PROVINCE: (B)(6). COMPLAINANT COUNTRY: JAPAN. BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. THIS COMPLAINT HAS BEEN EVALUATED. NO LOT NUMBER IS AVAILABLE. A DETAILED INVESTIGATION OR BATCH REVIEW CANNOT BE CONDUCTED. THEREFORE, THIS EVALUATION WILL BE CLOSED. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER REPORTING SITE: 1049092 MANUFACTURING SITE: 9618003.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION - THIS EMDR IS BEING SUBMITTED TO INCLUDE THE BELOW: H6: INVESTIGATION RESULTS UNDER TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS. H11: INVESTIGATION SUMMARY. REQUEST WAS PERFORMED FOR ADDITIONAL INFORMATION INCLUDING LOT NUMBER; HOWEVER, LOT NUMBER WAS NOT PROVIDED. A COMPLAINT INVESTIGATION WAS INITIATED UNDER COMPLAINT INVESTIGATION IN DATABASE. UNFORTUNATELY, NO SPECIFIC LOT NUMBER WAS IDENTIFIED, WHICH LIMITS THE ABILITY TO TRACE OR ANALYZE A PARTICULAR ITEM. CURRENT QUALITY CONTROLS DURING THE MANUFACTURING PROCESS: SINCE THE COMPLAINT DID NOT INCLUDE A SPECIFIC LOT NUMBER, THE INVESTIGATION USED THE PART NUMBER AND PRODUCT DESCRIPTION PROVIDED TO IDENTIFY THE CORRESPONDING MANUFACTURING LINE, THE RELEVANT PRODUCT: EST+ DRNPRECUTINVISICLR28MM(1X10) NAI. BASED ON THIS INFORMATION, PROCESS INSTRUCTION (PI), CORRESPONDING TO THE 23A, WAS IDENTIFIED. THE ASSOCIATED IN PROCESS CONTROLS WERE REVIEWED TO CONFIRM THAT THE CONTROLS ESTABLISHED FOR THIS MANUFACTURING LINE ARE ADEQUATE TO DETECT AND PREVENT THE REPORTED FAILURE MODE. TEST METHODS (TM) "POUCH NON CONFORMITIES": FREQUENCY: HOURLY. SAMPLE QUANTITY: 10 POUCHES. ACCEPTANCE CRITERIA: ACCEPT 0 / REJECT 1. ADHESIVE DISC TO FABRIC COLLAR CONCENTRICITY: FREQUENCY: HOURLY. SAMPLE QUANTITY: 10 POUCHES. ACCEPTANCE CRITERIA: ACCEPT 0 / REJECT 1. TEST METHODS (TM) "VISUAL NONCONFORMITIES": FREQUENCY: HOURLY. SAMPLE QUANTITY: 10 POUCHES. ACCEPTANCE CRITERIA: ACC0 / REJ1. DIMENSION TEST - DRAWING: FREQUENCY: TWICE PER SHIFT (APROX. EVERY 4 HOURS). SAMPLE QUANTITY: 1 POUCH PER HEAD. ACCEPTANCE CRITERIA: ACCEPT 0/ REJECT 1. RISK MANAGEMENT: ALL INSPECTIONS AND CONTROLS ARE DOCUMENTED IN (B)(4) ANALYSES FOR THE DEVICE SPECIFICATION. THE SEVERITY OF POTENTIAL FAILURE MODES IS RATED AS 1 (LOW), AND THE OCCURRENCE IS 1 (REMOTE). ACCORDING TO RISK MANAGEMENT PROCEDURE, STANDARD OPERATING PROCEDURE (SOP), THE LIKELIHOOD OF HARM TO THE END USER IS CONSIDERED HIGHLY UNLIKELY DUE TO THE EFFECTIVENESS OF THE CONTROLS IN PLACE. TREND ANALYSIS: AS PART OF THE INVESTIGATION, A REVIEW WAS CONDUCTED ON COMPLAINTS ASSOCIATED WITH THE MALFUNCTION "SKIN BARRIER STARTER HOLE IS DEFECTIVE (E.G MISALIGNMENT OR OFF CENTER), LEAKAGE MAY OCCUR (PRE-CUT ONLY)" FOR PRODUCTS MANUFACTURED ON 23A PRODUCTION LINE. THE ANALYSIS COVERED DATA FROM 2024 TO 2026. AS A RESULT, ONLY ONE (1) ADDITIONAL COMPLAINT WAS FOUND DURING THE REVIEW; THE FREQUENCY OBSERVED DOES NOT REPRESENT A TREND. THE ASSOCIATED INVESTIGATIONS DID NOT IDENTIFY ANY MANUFACTURING ISSUES, PROCESS DEVIATIONS, OR MATERIAL RELATED FACTORS THAT COULD EXPLAIN THE REPORTED BEHAVIOR. BASED ON THE INFORMATION AVAILABLE, THE MALFUNCTION CANNOT BE ATTRIBUTED TO A SYSTEMIC ISSUE RELATED TO THE POUCH OR THE PRODUCTION LINE, AND THEREFORE, NO TREND IS OBSERVED. PERSONNEL NOTIFICATION AND TRAINING: AS PART OF THE INVESTIGATION, THE TEAMS INVOLVED IN THE MANUFACTURING OF THE AFFECTED PRODUCT WERE INFORMED ABOUT THE REPORTED ISSUE. THE GOAL WAS TO RAISE AWARENESS AND REINFORCE THE IMPORTANCE OF INSPECTION PROTOCOLS, ESPECIALLY CONSIDERING THAT NO SPECIFIC LOT NUMBER WAS AVAILABLE. THE NOTIFICATION SESSIONS SERVED AS A REMINDER TO REMAIN VIGILANT AND MAINTAIN HIGH STANDARDS IN DAILY OPERATIONS. THIS EFFORT HELPED ENSURE THAT EVERYONE INVOLVED CONTINUES TO FOLLOW ESTABLISHED CONTROLS AND REMAINS ATTENTIVE TO ANY SIGNS OF DEVIATION, EVEN IN CASES WHERE PRODUCT TRACEABILITY IS LIMITED. FOR FURTHER DETAILS, REFER TO THE TAB "REFERENCE INFO / COMMENTS" IN THE COMPLAINT INVESTIGATION RECORD: "20MAR2026 - PERSONAL NOTIFICATION - IN DATABASE". CONCLUSION: BASED ON THE INFORMATION AVAILABLE, THE INVESTIGATION COULD NOT IDENTIFY THE SPECIFIC LOT NUMBER ASSOCIATED WITH THE REPORTED EVENT, WHICH LIMITED THE ABILITY TO PERFORM A TARGETED REVIEW OF MANUFACTURING RECORDS. HOWEVER, ALL APPLICABLE IN[?]PROCESS CONTROLS, UPSTREAM MATERIAL EVALUATIONS, AND QUALITY INSPECTIONS FOR 23A LINE. NO PROCESS DEVIATIONS, MATERIAL ISSUES, OR MANUFACTURING ABNORMALITIES WERE IDENTIFIED THAT COULD CONTRIBUTE TO THE REPORTED FAILURE MODE. A TREND ANALYSIS OF COMPLAINTS ASSOCIATED WITH MALFUNCTION SKIN BARRIER STARTER HOLE IS DEFECTIVE (E.G MISALIGNMENT OR OFF CENTER), LEAKAGE MAY OCCUR (PRE-CUT ONLY) FOR PRODUCTS MANUFACTURED ON 23A LINE BETWEEN 2024 AND 2026. AS A RESULT ONLY ONE (1) ADDITIONAL COMPLAINT WAS IDENTIFIED; THIS DOES NOT CONSTITUTE A TREND. THE AVAILABLE EVIDENCE DOES NOT INDICATE A SYSTEMIC ISSUE WITHIN THE MANUFACTURING PROCESS OR PRODUCT DESIGN. FURTHERMORE, NO HARMS WERE REPORTED IN ASSOCIATION WITH THIS COMPLAINT. INVESTIGATION OUTCOME: NO SYSTEMIC ISSUE WAS DETECTED. THE COMPLAINT APPEARS TO BE AN ISOLATED CASE WITH NO EVIDENCE OF RECURRING PRODUCT FAILURE. BASED ON THE AVAILABLE DATA AND CONTROLS IN PLACE, THE INVESTIGATION OUTCOME IS INCONCLUSIVE, WITH A LOW RISK OF RECURRENCE. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS, STANDARD OPERATING PROCEDURE (SOP). TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER: REPORTING SITE: 1049092. MANUFACTURING SITE: 9618003.

Description of Event or Problem

TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.